About this trial
This study seeks to develop early recognition tools specially designed for children meeting the Phoenix definition and explore implementation science aspects by investigating facilitators and barriers to adopting Phoenix sepsis criteria in clinical practice. This addresses the critical need for systemic, evidence-based approaches to paediatric sepsis identification across diverse healthcare settings in Asia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children < 18 years old
Suspected infection defined by (1) blood culture performed (irrespective of result), AND (2) use of broad-spectrum anti-microbial agents, in the first 24 hours of admission
Disqualifiers
18 years and older
Patients who discharge At Own Risk (AOR) without outcome data
Trial population
Children \< 18 years old with suspected infection. Suspected infection is defined as children who undergo blood cultures and receive broad-spectrum anti-microbial agents in the first 24 hours of admission. Anti-microbial agents include antibiotics, antiviral, antifungal and antimalarial medications.
Trial design
Cohort
Other
Treatments tested in this trial
Application of the Phoenix Sepsis Score
Other interventionData Variables in the first 24 hours of hospital admission as per Phoenix Sepsis Score: Including that of respiratory function (PaO2:FiO2 and SpO2:FiO2 ratios, need for oxygen, high-flow, non-invasive or mechanical ventilation support), cardiovascular function (including need for vasoactive medications, lactate value and mean arterial pressure), coagulopathy (measured using platelets, International Normalized Ratio, D-dimer and Fibrinogen), neurologic dysfunction (measured with Glasgow Coma Scale and presence of fixed pupils), endocrine (blood glucose), immunologic (absolute neutrophil and absolute lymphocyte count), renal (creatinine levels) and hepatic (total bilirubin and alanine transaminase). Data from the Emergency Departments will need to be linked to inpatient records to obtain the worst values in each domain that occurred in the first 24 hours.
Treatment groups
Trial outcomes
Primary outcomes
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under the receiver operating characteristic curve (AUROC).
Performance of Phoenix Sepsis Score in Pediatric Acute and Critical Care Medicine in Asia Network (PACCMAN) sites in Asia
Following Specific Aim 1: The primary outcome measure is to validate the Phoenix Sepsis Score in PACCMAN sites in Asia, with the clinical outcome of Mortality. The performance will be measured using area under precision recall curve (AUPRC). The investigators will also measure the performance using sensitivity, specificity, positive and negative predictive values.
Derivation of an early recognition tool called Sepsis Optimal Recognition Toolkit in children (SORT)
Following the second specific Aim, the outcome is for the model SORT to be derived with a sensitivity of 90% and a c-statistic of at least 0.80 in predicting for sepsis as defined by a Phoenix Sepsis Score ≥ 2.
Sponsors and contacts
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KK Women's and Children's Hospital
Lead sponsor
National Medical Research Council (NMRC), Singapore
Collaborator